Are you a senior expert in medical device regulatory affairs with experience of consulting as well as experience from leadership? Would you like to use your knowledge to support innovative companies in setting up strategies and navigate the regulatory landscape? Then this position at RegSmart could be something for you!
About us
RegSmart Life Science is a rapidly growing regulatory consultancy firm in pharma and medical device that facilitate the development process for companies in the Life Sciences and help them navigate in a complex and evolving regulatory landscape.
Our motto is Regulatory Relevant & Scientifically Sound.
We are a great team of experts with extensive regulatory experience and firm scientific knowledge who use our collective experience in regulatory affairs to make a difference in every project. Take a look at our staff: https://regsmart.se/board/
The company is located in Uppsala and there are great possibilities to work either from a distance or at the office. RegSmart offers competitive terms and are flexible when it comes to starting date and working hours. With strong finances and high demand for our services, the future looks prosperous!
Work description
Are you a senior expert in medical device regulatory affairs with experience of consulting as well as experience from leadership?
Would you like to use your knowledge to support innovative companies in setting up strategies and navigate the regulatory landscape?
As Director regulatory within medical device at RegSmart we welcome you to play a fundamental part of the future growth for the company.
If you also want to work in a team-oriented and supportive environment together with other senior experts in a fast-growing company, this may be your next job!
Responsibilities include:
• Lead the business development of regulatory, medical device at RegSmart.
• A major part of this role is to consult clients & projects based on your competences within medical device regulatory affairs.
• Responsible for the personnel in the regulatory team of medical device.
• Being part of the management team.
• Responsible for planning and following up the budget.
• Travelling to participate in conferences and to meet customers.
Your profile
The most important thing to succeed as Director, regulatory, is to be able to share your profound expertise to our clients and to coach your team.
It’s beneficial if you have extensive regulatory knowledge and/or experience in one or more of the following areas:
• Requirements for medical devices according to MDR/IVDR for CE marking in EU / FDA approval.
• Development of medical devices
• Drug-device combination products
• Digital health devices; medical device software and applications, including cyber security
• In vitro diagnostic medical devices regulations (IVDR)
• Cinical evaluation and investigation of medical devices
• Compilation and review of technical files to comply with regulations/ISO standards/ guidelines
• Communication with notified bodies / FDA including compiling regulatory files
• Experience as inspector or reviewer from regulatory agency or notified body.
• Managing post market surveillance processes.
You also need an academic degree in science or engineering and a professional level of English.
To enjoy your work at RegSmart, we think that you are science-driven, good at expressing your opinions with the recipient in mind, as well as interested in finding effective solutions to our clients’ needs. Furthermore, we believe that you enjoy interacting with new contacts as this will be a great part of this role.
Does this sound interesting?
In this recruitment process, we collaborate with Clockwork Recruitment & Staffing. Submit your application at www.clockworkpeople.se no later than January 29. If you have questions, please contact recruitment consultant Mattias Gäreskog on 0733-51 27 09 or via email: mattias.gareskog@clwork.ce
To ensure sustainable recruitment, we at Clockwork are keen to have an equal and inclusive selection in all of our processes we help our customers with. With the help of a wide selection and with a competence-based methodology as a basis, we ensure that you who apply are treated equally.